Freedom of Information – Focus on Regulationhttps://www.hlregulation.com
Thu, 23 May 2019 23:42:36 +0000en-UShourly1https://wordpress.org/?v=4.9.10FDA aims to harmonize its human subject protection regulations with Common Rulehttps://www.hlregulation.com/2018/10/29/fda-aims-harmonize-human-subject-protection-regulations-common-rule/
Mon, 29 Oct 2018 20:43:36 +0000https://www.hlregulation.com/?p=10834On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January

]]>On October 12, FDA published guidance for sponsors, investigators, and IRBs titled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The guidance outlines FDA’s expectations for clinical research that is subject to both the FDA’s human subject protection regulations and DHHS’ recently revised Common Rule, which takes effect in January 2019. FDA’s rules on human subject protection govern clinical investigations regulated by FDA under sections 505(i) and 520(j) of the FDCA, as well as studies used to support applications for research or marketing permits for products regulated by FDA, while the DHHS Common Rule covers DHHS federally funded research. FDA’s recent guidance discusses informed consent requirements, expedited review procedures, and IRB continuing review.

Importantly, this guidance makes clear that research subject to FDA rules must continue to abide by those regulations, even when they are more restrictive than the Common Rule. For instance, FDA maintains the requirement, eliminated in the revised Common Rule, that some low-risk studies undergo an annual check-up known as “continuing review.” However, IRBs should apply Common Rule measures governing structure and content of informed consent documents, which do not conflict with any FDA regulations. As one example, the revised Common Rule includes a new requirement that all the key information in informed consent forms be at the top of the form; FDA does not yet require this.

FDA to update rules to match Common Rule provisions

In order to harmonize FDA’s regulations for the Protection of Human Subjects and Institutional Review Boards (IRBs) with the recently revised final HHS Common Rule, FDA plans to issue three more guidances. The White House’s fall 2018 regulatory agenda, released October 17, indicated FDA plans to go through the formal proposed rulemaking process to finalize these rules, meaning the agency will accept and consider public comments before issuing the guidances in final form. The three planned FDA guidances are:

RIN 0910-AI07, “Part 50 Protection of Human Subjects and Part 56 Institutional Review Boards,” which would add new definitions and conforming language to FDA rules.

RIN 0910-AH52, “Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations,” which would align FDA rules with the Common Rule provision permitting an IRB to waive or alter the informed consent requirements under certain conditions for minimal risk clinical investigations in order to support the development of new products to diagnose or treat disease, or to address unmet medical needs.

RIN 0910-AI08, “Institutional Review Boards; Cooperative Research,” which addresses the “single IRB” provision in the Common Rule (the provision that requires each research institution participating in a multi-site study to use the same IRB). This planned guidance is the only one of the three guidances deemed “economically significant” and the only one that was always intended to have a comment period.

Previous OHRP guidances on Common Rule revisions

HHS’ Office for Human Research Protections (OHRP) has also separately issued three draft guidances on the Common Rule revisions on July 20, titled:

Draft guidance: Scholarly and Journalistic Activities Deemed Not to be Research: 2018 Requirements

Draft guidance: When Continuing Review Is Not Required During the 6-Month Delay Period of July 19, 2018 through January 20, 2019: 2018 Requirements

]]>On October 15, CMS released a proposed rule titled “Medicare and Medicaid Programs: Drug Pricing Transparency,” which would require direct-to-consumer (DTC) advertisements for prescription drugs covered by Medicare or Medicaid to include the Wholesale Acquisition Cost (WAC). This proposed rule resembles a rejected Senate amendment to the FY-2019 Labor-HHS-Education appropriations bill (analyzed here) that would have provided HHS $1 million to implement rules requiring manufacturers to disclose drug list prices in DTC advertising; however, House Republicans declined to adopt that amendment.

Specifically, the proposed rule would require DTC advertisements to include a text statement disclosing the WAC for a typical 30-day regimen or for a typical course of treatment, whichever is most appropriate. No voiceover would be required. The proposed rule includes an exception for drugs with a WAC of less than $35 per month.

Enforcement by private right of action

This proposed rule is the Administration’s latest step in response to ongoing scrutiny on drug pricing and transparency as highlighted in President Trump’s May 2018 Blueprint to lower drug prices. However, it is notable that the Blueprint charged FDA with evaluating whether and how to require manufacturers to include list prices in advertising; yet, the proposed rule was released by CMS and not FDA, and is based on CMS’ authority to regulate the Medicare and Medicaid programs.

This proposed enforcement mechanism relies primarily on a private right of action under existing competition laws and, secondarily, public admonition by CMS. Under the proposed rule, HHS would maintain a public list of drugs advertised in violation of the rule, but the rule anticipates that the primary enforcement mechanism would be the potential of private suits under the Lanham Act for unfair competition in the form of false or misleading advertising.

PhRMA to voluntarily direct consumers to price info

Shortly before HHS Secretary Alex Azar announced the proposed rule, Pharmaceutical Research and Manufacturers of America (PhRMA) President Stephen Ubl announced the group’s members each agreed to voluntarily include in TV ads directions for consumers to find drug pricing information on the manufacturers’ websites. Under this initiative, which starts April 15, 2019, information available online will include the drug’s WAC as well as a range of potential out-of-pocket costs patients might pay. Primarily, PhRMA’s initiative differs from CMS’ proposal in that it is entirely voluntarily, and it involves drug makers directing consumers to pricing information rather than directly stating costs in DTC ads.

In response, Azar criticized PhRMA’s initiative as inadequate, saying, “Our vision for a new, more transparent drug-pricing system does not rely on voluntary action.” PhRMA asserted that including the WAC in commercials may discourage patients from seeking needed medical care. Similarly, J&J CFO Joseph Wolk said listing WACs on TV ads “could be somewhat confusing and actually act as a deterrent to good, responsible health care and we just want to make sure that that doesn’t play out that way,” Bloomberg reported.

Rule subject to legal attack

As we previously discussed here, this measure may raise First Amendment concerns as a form of compelled speech. Second, there is question over whether CMS has authority to implement this regulation. Neither the Food Drug and Cosmetic Act (FDCA) nor FDA’s implementing regulations contemplate mandatory disclosure of drug prices in promotional materials, and it is difficult to see how the failure to include pricing information is thus misleading to consumers. Meanwhile, CMS’ authority is tied specifically to Medicare and Medicaid.

Solicitation of comments

CMS said it is soliciting specific comment on a number of issues, including:

Whether the proposed regulations should apply to advertisements in other media, such as print ads or radio.

Whether compliance with the rule should be a condition of payment from federal health programs.

Whether WAC is the best measure for the stated purposes of price transparency and comparison shopping.

How to treat an advertised drug that must be used in combination with another non-advertised drug or device.

The potential effects of the proposed rule, including how manufacturers set the WAC for advertised products, and how patient behavior may change in response to this pricing information.

CMS will accept public comments on the Proposed Rule until December 17, and HHS expects the new requirement would take effect 30 days after publication of a final rule. If you have any questions or want to discuss submitting a comment, please contact any of the authors listed below or the Hogan Lovells attorney with whom you regularly work.

]]>Closing the stable door after another horse has bolted: The Information Rights Tribunal confirms the persuasiveness of other public authority decisions on disclosure of similar commercially confidential informationhttps://www.hlregulation.com/2016/06/08/closing-the-stable-door-after-another-horse-has-bolted/
Wed, 08 Jun 2016 15:18:15 +0000http://www.hlregulation.com/?p=8633The First-tier Tribunal (Information Rights) (“FtT“) has published an interesting decision on the disclosure of commercially confidential information. In John Eustace v The Information Commissioner, Southampton City Council (the “Council“) was ordered to disclose commercial information relating to the revenue stream it received from bus stop advertising, in part because other local authorities had been

]]>The First-tier Tribunal (Information Rights) (“FtT“) has published an interesting decision on the disclosure of commercially confidential information. In John Eustace v The Information Commissioner, Southampton City Council (the “Council“) was ordered to disclose commercial information relating to the revenue stream it received from bus stop advertising, in part because other local authorities had been happy to disclose the same type of information in the past. These previous disclosures meant that the FtT regarded it less likely that disclosure would prejudice commercial interests in this case. Following this decision, it may be difficult for a public authority to justify non-disclosure if a different public authority has already disclosed information of the same type.

Facts

An advertiser had a contract to place advertisements in bus shelters owned by the Council. In the past, advertising space at bus shelters consisted of hard copy posters which had to be changed manually. However, Southampton Council introduced the use of digital panels at Council owned bus stops, which can show multiple advertisements in succession at a lower cost for maintenance. The applicant was concerned that this had obvious revenue benefits to advertisers but that those benefits were not necessarily being passed on to the Council. The applicant therefore requested the disclosure of “the financial benefits to Southampton City Council annually and over the life of the contract“. The Council refused the request on the grounds that the information was exempt from disclosure under section 43(2) FOIA which states:

Information is exempt information if its disclosure under this Act would, or would be likely to, prejudice the commercial interests of any person (including the public authority holding it).

This decision was upheld by the Information Commissioner on appeal.

First-tier Tribunal Decision

The applicant appealed to the FtT, arguing that the Information Commissioner’s decision was flawed because other local authorities had, in the past, disclosed information about their revenue streams from bus stop advertising. The Applicant argued that disclosure of this type of information could therefore not cause commercial prejudice within the meaning of s.43(2) FOIA. The ICO had distinguished this case from previous disclosures because the contract was more recent than previous disclosed contracts and it had been negotiated in an “unchanged” market. In the view of the ICO, this meant that disclosure would prejudice the Council’s commercial interests as anyone tendering for a future contract would know the price the Council would accept for the advertising space.

The FtT stated that if there is no clear material distinction to be drawn between this case and others where information has been disclosed, the previous disclosure may have some bearing on the question of likely prejudice to commercial interests.

Applying this test, the FtT found that there was no clear material distinction between this case and others. Although the contract was only four years old, the “digital revolution” had meant that the market had changed and when any future negotiation took place any advertiser would know that the old price would not be relevant. The FtT therefore treated the fact that the same type of information had previously been disclosed as a material consideration in its decision that the s.43(2) FOIA exemption did not apply.

Comment

While the FtT also applied the usual factors for determining whether commercial interests are prejudiced, this decision is an interesting insight into how the FtT will treat previous decisions by public authorities on the disclosure of similar information. Although each case should be treated as a separate matter requiring individual assessment, the FtT clearly suggested that if one public authority is willing to disclose commercial information in relation to a specific topic, another public authority may struggle to resist disclosure on the basis of commercial confidentiality.

Therefore, while this is not an absolute rule, companies should be aware that previous disclosures may have some bearing on the question of likely prejudice. For this reason, companies contracting with public authorities should consider whether they have particular concerns about the disclosure of certain commercial information. If so, they may wish to first seek advice on whether information of the same type has been previously disclosed by another public authority before providing that information to the public authority.

]]>Open Government National Action Plan aims to increase transparency in government over the course of 2016-2018https://www.hlregulation.com/2016/05/26/open-government-national-action-plan-aims-to-increase-transparency-in-government-over-the-course-of-2016-2018/
Thu, 26 May 2016 09:28:52 +0000http://www.hlregulation.com/?p=8610Following a Conservative manifesto commitment in 2015 to increase transparency in government, the Cabinet Office has published the UK Open Government National Action Plan 2016-2018. This is the third National Action Plan (“NAP“) since the United Kingdom co-founded the Open Government Partnership in 2011, which now includes 69 countries. The new NAP makes 13 commitments

The new NAP makes 13 commitments in relation to transparency, anti-corruption and open government. In particular, the NAP aims to address certain recommendations made by the Independent Commission on Freedom of Information (the “Commission“), which published its final report in March 2016. In Commitment 8 of the NAP, the Government pledges to make plans for enhanced transparency measures, including data about senior pay and benefits for Government officials, and to update and expand the Code of Practice under s.45 of the Freedom of Information Act 2000 (“FOIA“).

Senior Government pay and benefits

While there are existing obligations in relation to the disclosure of information regarding the pay of senior Government officials, the Commission was firmly of the view that more could be done. The Commission’s report recommended greater proactive transparency about senior executive pay and benefits, which could be achieved through requiring public bodies to publish in their annual statement of accounts a breakdown of the benefits in kind and expenses of senior employees. The NAP acknowledges that information on senior pay and benefits increases transparency, and that the public should not have to resort to making information access requests under FOIA for such transparency to be achieved. The Cabinet Office intends to issue guidance to public authorities to set a higher standard for the publication of senior level pay and benefits by this summer.

FOIA Code of Practice

The Code of Practice sets out the practice that the Government considers desirable for public bodies to follow in meeting their obligations under FOIA. However, it was issued in 2004, which was before FOIA came into force, and has not been updated since.

The Commission recommended that the government review and update the Code to take account of the ten years of operation of FOIA. An updated Code will be more useful for public authorities as it will take into account the various legal developments since 2004 that frame their FOIA obligations. In theory, this should mean that public authorities find it easier to respond to requests under FOIA. According to the NAP, the Cabinet Office will consult on and issue a new Code of Practice by the end of this year.

An increased culture of openness?

Following the publication of the Commission’s final report we suggested that supporters of FOIA remain cautiously hopeful that FOIA will continue to work well. While the exact form of the Government’s plans is yet to be confirmed, those same supporters will continue be heartened by a commitment to implement the recommendations of the Commission over the course of this year.

]]>The Independent Commission on Freedom of Information issues call for evidencehttps://www.hlregulation.com/2015/10/23/the-independent-commission-on-freedom-of-information-issues-call-for-evidence/
Fri, 23 Oct 2015 14:44:06 +0000http://www.hlregulation.com/?p=8043The Independent Commission on Freedom of Information has recently issued a call for evidence as part of a review which may herald comprehensive changes to the Freedom of Information Act 2000 (“FOIA“). The Commission, established amid concerns that the current regime does not adequately protect sensitive information (see our previous blog post), will consider how

]]>The Independent Commission on Freedom of Information has recently issued a call for evidence as part of a review which may herald comprehensive changes to the Freedom of Information Act 2000 (“FOIA“).

The Commission, established amid concerns that the current regime does not adequately protect sensitive information (see our previous blog post), will consider how best to balance the public interest in transparency and accountability, and the need for sensitive information to be protected.

The deadline for responses is midnight on Friday 20 November 2015.

Greater protection for public authorities?

The first area under scrutiny is whether FOIA provides “a “safe space” for policy development and implementation and frank advice“. This “safe space” covers three strands:

the deliberative space, in which ministers and officials can discuss policies frankly;

Cabinet’s collective responsibility, allowing ministers to express their views honestly in private, whilst maintaining a publically united front; and

risk assessments, which must fully detail the risks of policies in development.

Under the qualified exemptions in ss. 35 and 36 FOIA, information relating to policy development may only be withheld if there is a public interest in doing so. The Commission’s questions suggest that it is considering whether these exemptions should be extended, for example applying absolutely for a minimum time following a policy decision, regardless of public interest.

Additionally, the Commission is considering whether a ministerial veto should exist following the Supreme Court’s judgment restricting use of the veto in Evans v Attorney General. The Commission may recommend greater powers for ministers to veto FOIA requests or suggest further safeguards to ensure that previously vetoed information remains protected.

The cost of reducing the burden

To reduce the burden on public authorities, the Commission is contemplating introducing a fee for making a FOIA request. Although it was expected, during the passage of the Freedom of Information Bill, that a fee would be charged for making a request, no such requirement was ultimately implemented. The Commission notes that fees for information requests are common in other jurisdictions and that fees are currently charged in the UK for similar information access schemes, such as a subject access request under the Data Protection Act 1998. The introduction of a fee may well have a deterrent effect on requests for information under FOIA.

Public authorities may currently refuse FOIA requests where the cost will exceed certain limits. The Commission, however, highlights that only certain activities are counted in calculating the cost of a request. Activities such as reading and redacting the information are not included. The Commission seems to be considering the possibility of expanding the range of activities that are counted, which could enable public authorities to refuse more requests on cost grounds.

Comment

Although there is a clearly a need for some protection to allow effective policy development, the Commission’s proposals definitely represent an attempt to decrease the transparency and accountability currently afforded by the FOIA regime. Introducing fees and making it easier for public authorities to refuse requests on cost grounds would inevitably cause a drop in successful FOIA requests: the Commission will need to be careful to balance the importance of the public’s right to access information against the burden on public authorities.

]]>Cabinet Office Announces Commission to Review Freedom of Information Legislationhttps://www.hlregulation.com/2015/07/22/cabinet-office-announces-commission-to-review-freedom-of-information-legislation-2/
Wed, 22 Jul 2015 09:06:13 +0000http://www.hlregulation.com/?p=7839The Cabinet Office has recently announced that a cross-party commission is to look into the Freedom of Information Act 2000 (“FOIA”) in light of apparent concerns that sensitive information is not being sufficiently protected. FOIA was introduced under the last Labour Government, coming fully into force on 1 January 2005, and allows a private citizen

]]>The Cabinet Office has recently announced that a cross-party commission is to look into the Freedom of Information Act 2000 (“FOIA”) in light of apparent concerns that sensitive information is not being sufficiently protected.

FOIA was introduced under the last Labour Government, coming fully into force on 1 January 2005, and allows a private citizen to obtain information held by public bodies across the UK, with a number of exceptions including for confidential, sensitive or personal information.

In a written statement in Parliament, Lord Bridges, Parliamentary Secretary for the Cabinet Office, explained that, “we fully support the Freedom of Information Act but after more than a decade in operation it is time that the process is reviewed, to make sure it’s working effectively“.

The Commission will look at whether FOIA strikes the right balance between, on the one hand, ensuring that public bodies are transparent and accountable; and, on the other hand, recognising the need for sensitive information to have “robust protection” and ensuring that there is a “safe place” in which public authorities can develop and implement policy. In particular, one of the Commission’s key aims appears to be to ensure that civil servants are able to give ministers “frank” advice in this context.

The Commission may also consider the burden placed on public authorities by FOIA in requiring them to respond to information requests and whether the rules should be moderated to make it easier for them to refuse requests whilst still ensuring that the public has access to information.

The Commission will be chaired by Lord Burns, a senior Treasury civil servant, and its members will include: former Conservative Home Secretary, Lord Howard; his Labour successor, Jack Straw; Lord Carlile, a former Independent Reviewer of Terrorism Legislation; and Dame Patricia Hodgson, Chairman of Ofcom.

The panel’s composition has been criticised for being unbalanced as it will be wholly staffed by civil servants and former ministers. Former Home Secretary David Davis has argued that a journalist or civil rights campaigner should be appointed saying, “if you don’t put all points of view on [the panel], it is harder for people to have confidence in its findings“.

The Commission will report to the Minister for the Cabinet Office and will publish its findings by the end of November 2015.

This is not the first time that those in office have seen the need to review FOIA. Tony Blair famously said in his memoirs that he regretted introducing FOIA since it removed the last vestiges of Government confidentiality and was not used by “the people” but by journalists instead. In 2006, Tony Blair’s Labour Government tried to introduce legislative proposals to make it easier for public authorities to refuse FOIA requests on “cost grounds” (for example, requests which were complex, sensitive or raised public interest issues would have been likely to be refused on cost grounds, regardless of their merits). If they had been passed, these proposals would have severely restricted the amount of information that could have been obtained under FOIA. In 2010, FOIA was amended to include, among other things, an exemption for communications with the Queen, other members of the Royal Family and the Royal Household, and the awarding of honours by the Crown. Certain information relating to the sovereign and to the heir and second in line to the throne became absolutely exempt from FOIA, whereas information relating to other members of the royal family and the royal household remained subject to a public interest test.

However, most recently, in a victory for freedom of information, the Supreme Court in Evans v Attorney General ruled that the Attorney General could not rely on the veto in section 53 FOIA to override the Upper Tribunal decision to disclose Prince Charles’s private correspondence with ministers merely because he took a different view from the tribunal. The Court found that clear words must be used if statute is intending to prevent courts and tribunals from reviewing the actions of the executive. It concluded that section 53 was far from being clear enough, particularly given that fundamental rights were at stake.

In the wake of Evans, it is perhaps unsurprising that the Government wishes to clarify the use of FOIA. However, it remains to be seen whether the new Commission will see its mission as protecting the Government’s right to confidentiality or protecting the public’s “right to know” Government information.

]]>What will be the impact of the new EU Data Protection Regulation on the UK’s Freedom of Information Act?https://www.hlregulation.com/2015/02/12/what-will-be-the-impact-of-the-new-eu-data-protection-regulation-on-the-uks-freedom-of-information-act/
Thu, 12 Feb 2015 18:38:56 +0000http://www.hlregulation.com/?p=7463The future of the s. 40 exemption Undoubtedly one of the more mind-bending exemptions to apply under the Freedom of Information Act 2000 (FOIA) is the exemption for personal information (s.40) (although sections 30 and 36 are also up there!). This is partly due to s. 40’s close link with the Data Protection Act 1998

Undoubtedly one of the more mind-bending exemptions to apply under the Freedom of Information Act 2000 (FOIA) is the exemption for personal information (s.40) (although sections 30 and 36 are also up there!). This is partly due to s. 40’s close link with the Data Protection Act 1998 (DPA). Not one to hog the limelight, the DPA has typically been cited in past litigation as a secondary or even tertiary issue to the main action when there is a claim for breach of confidence or breach of privacy. This led to a scarcity of judicial rulings on the DPA prior to the FOIA. However, in the Tribunal and higher court decisions flowing from the FOIA, certain aspects of the DPA have frequently been examined when public authorities seek to rely on the s. 40 exemption. Consequently there have been a number of rulings on the scope of personal data and on the ‘legitimate interests’ ground as a legal basis for disclosing such information. These rulings have been based on the DPA which itself implements the EU Data Protection Directive 95/46/EC. But the Directive is due to be replaced by an EU Regulation in the next few years. What will this mean for how the s. 40 exemption under FOIA is interpreted?

The new EU Data Protection Regulation

The final text of the EU Data Protection Regulation is not yet agreed and discussions are on-going within the EU. However, we can be fairly sure of a number of implications at this stage. In particular, the new EU Data Protection regulatory framework will be presented as a Regulation and not a Directive. A Regulation has direct applicability in UK law which will almost certainly lead to the repeal of the DPA. Therefore, it is likely that the FOIA will need to be amended to reflect the repeal of the DPA and refer to the new law – the Regulation.

Additionally, it seems certain that the new Regulation will be more prescriptive than the DPA and there will be reduced scope for national particularisation. This means that the interpretation of certain key concepts of data protection may change from those commonly understood in the context of the s. 40 exemption. At the moment, the Information Commissioner (ICO), Information Tribunal and other courts are bound by UK court decisions on the interpretation of the DPA when considering s.40. So, for instance, when the courts examined whether abortion statistics were personal data as part of the Department of Health v ICO litigation, they considered a previous House of Lords decision on the meaning of personal data under the DPA. The repeal of the DPA will require the ICO, Tribunal and courts to interpret s. 40 in the light of rulings on the Regulation. Where there are no rulings on the Regulation in the UK, they may potentially look at rulings on the Regulation in other Member States as well as previous rulings on similar provisions in the DPA. But this latter course could become problematic if the underlying principles in the Regulation differ from the DPA.

What will this mean for the definition of personal data?

The UK has been criticised over the years for not properly implementing the Data Protection Directive into UK law. Indeed, judicial decisions such as the 2003 Court of Appeal Durant decision which advocated a narrower definition of personal data are generally considered to be anomalous. Understanding the different limbs of what comprises personal data with any precision under current law can itself be a tortuous exercise. The DPA defines personal data as data which is identifiable by the data controller but does not refer to identification by another party. However, the latest drafts of the Regulation (echoing the position under the Directive) state that ‘to determine whether a person is identifiable, account should be taken of all the means likely to be used either by the controller or by any other person to identify the individual directly orindirectly‘ (my emphasis). Consequently, in applying the Regulation in the context of s. 40, the UK regulator and courts would be required to take account of this broader definition of personal data (which was the original intention of the Directive).

What will this mean for reliance on the legitimate interest ground?

Once personal data has been identified as the subject of a FOI request, the next step under the current s. 40 exemption (and assuming the request is not a subject access request) is to consider whether disclosure of the personal data under FOIA would contravene any of the data protection principles under the DPA. In most instances this is the limb that will trigger the application of s. 40 rather than the other limbs – including the right to object under s. 10 DPA or the SAR exemptions – which are rarely relied on. If disclosure would contravene the principles (and in reality, only the first principle – fair and lawful processing is in the picture) then the s. 40 exemption applies and disclosure is not required. In examining whether disclosure of the personal data under FOIA is fair and lawful, public authorities consult Schedule 2 of the DPA to consider whether it can rely on any of the listed lawful grounds and ‘legitimate interests’ is the ground usually relied upon.

Now, replace the DPA with the Regulation. The equivalent of Schedule 2 of the DPA in the Regulation is currently Article 6 (Lawfulness of processing). In order to argue that a disclosure of personal data is lawful under FOIA in the context of the Regulation, the public authority would need to be able to rely on one of the lawful grounds listed – with consent and legitimate interest being the most likely candidates. Consent is for various reasons always a tough nut to crack and so, as is the case currently, most public authorities would still primarily examine the legitimate interests ground in order to consider whether the s. 40 exemption is available.

However, there has been some uncertainty over whether the legitimate interest ground will be available for public authorities to rely on at all under the Regulation. The EU Commission’s initial draft of the Regulation in January 2012 stated specifically that the legitimate interest ground would not apply to processing carried out by public authorities in the performance of their tasks. This more restrictive approach to the legitimate interest ground partly reflects different attitudes in other Member States. For instance, in the past, Spain, Hungary and Italy have adopted stricter approaches to the availability of legitimate interests. This restriction understandably alarmed the ICO who, in their February 2013 analysis paper of the Regulation, argued that there should be a gateway for legitimate processing triggered by access to information or freedom of information laws. Without this gateway it would become difficult (if not impossible) for a public authority to ever disclose personal data under FOIA since there would be no available lawful ground to do so and s. 40 would apply in every case.

Have the concerns of the ICO been heard by the EU institutions? Well, the latest EU Council draft of the Regulation from December 2014 continues to restrict public authorities from relying on the legitimate interests ground. However the draft indicates that a number of Member States (including the UK) wish to delete this restriction from Article 6. Since the status of the public sector has been a matter of sensitivity in the debates on the Regulation, it is not yet clear what the final position on this provision will be.

A possible solution

The latest draft of the Regulation proposed by the Council may provide another way through the problem. It acknowledges that personal data in documents held by a public authority should be publicly disclosable if provided for by Member State law. Additionally, amendments to Article 80 dealing with freedom of expression to include freedom of information indicates that Member States may be given discretion to adapt their national law to reconcile freedom of information with the Regulation. Likewise, there is a new Article dealing with public access to official documents which also suggests it will be for the Member State to determine how to reconcile the two sets of rules. These developments (if retained) should give the UK Government some flexibility to adapt the s. 40 exemption in a way that reflects its current use while not falling foul of the Regulation. In any event, the repeal of the DPA may provide the UK Government with an opportunity to simplify the s. 40 exemption under the Freedom of Information Act 2000 and dispose of those elements which are rarely used.

]]>FOIA: new research exemption comes into forcehttps://www.hlregulation.com/2014/10/09/foia-new-research-exemption-comes-into-force/
Thu, 09 Oct 2014 14:18:07 +0000http://www.hlregulation.com/?p=6955On 1 October, a new exemption (the “New Exemption“) relating to continuing programmes of research came into force under the Freedom of Information Act 2000 (“FOIA“). Its intention is to protect information pertaining to on-going research from premature disclosure. Section 22A FOIA – inserted by the Intellectual Property Act 2014 (“IPA“) – provides that information

]]>On 1 October, a new exemption (the “New Exemption“) relating to continuing programmes of research came into force under the Freedom of Information Act 2000 (“FOIA“). Its intention is to protect information pertaining to on-going research from premature disclosure.

Section 22A FOIA – inserted by the Intellectual Property Act 2014 (“IPA“) – provides that information “obtained in the course of, or derived from, a programme of research” is exempt information if the following criteria are satisfied:

(a) the programme is continuing with a view to the publication, by a public authority or any other person, of a report of the research (whether or not including a statement of that information), and

(b) disclosure of the information under [FOIA] before the date of publication would, or would be likely to, prejudice—

(i) the programme,

(ii) the interests of any individual participating in the programme,

(iii) the interests of the authority which holds the information, or

(iv) the interests of the authority mentioned in paragraph (a) (if it is a different authority from that which holds the information).

The New Exemption is not absolute, and a public authority seeking to rely on it will thus be required to assess whether the public interest in maintaining the exemption outweighs the public interest in disclosure.

The Ministry of Justice has published short guidance on the New Exemption. It notes, among other things, that its application is not limited to the first report that is based on the relevant research: “So long as any report of the research is still to be published, then information obtained in the course of, or derived from, the research programme falls within the scope of this exemption.” The aim of the New Exemption is thus to protect information pertaining to such projects until they are fully concluded.

The New Exemption is both class- and prejudice-based. So far as prejudice is concerned, in order for the New Exemption to be engaged public authorities will be required to demonstrate that the (now long-established) threshold is met, i.e. that:

(a) there is a causal link between disclosure and the prejudice claimed to one of the four factors set out in s. 22A(1) (b) (see above); and

In relying on the New Exemption, public authorities should be careful to assess, and state, the level of risk of the prejudice, and specify to the requester whether it considers that the prejudice “would” or “would be likely to” occur. Failure to do so could ultimately lead the Commissioner or a tribunal in any subsequent appeal against a refusal to disclose the information to presume that the lower threshold applies (see ICO guidance on the prejudice test).

What constitutes a “programme of research” is not defined in FOIA, although the parliamentary discussion on the IPA demonstrates that the rationale for the New Exemption was to afford protection to academic research, much like the exemption in s. 27(2) of the Freedom of Information (Scotland) Act 2002 (David Willets, then Minister for Universities and Science, referred to the implementation of the “Scottish exemption”). Nevertheless, in the context of collaborative programmes between public and private bodies, it will be interesting to see whether commercial entities will push public bodies to rely on the New Exemption alongside the protections already afforded by s.22 FOIA (information intended for future publication) and s.43 FOIA (commercial interest, including trade secrets).

]]>Off the record: Supreme Court sides with Charity Commission in FOIA appealhttps://www.hlregulation.com/2014/03/27/off-the-record-supreme-court-sides-with-charity-commission-in-foia-appeal/
Thu, 27 Mar 2014 16:52:39 +0000http://www.hlregulation.com/?p=6091The Supreme Court has ruled that the absolute exemption contained in s.32(2) of the Freedom of Information Act 2000 (“FOIA“) continues to apply to information obtained or created by a person conducting an inquiry even after the termination of that inquiry. The decision was not without dissent, however, with the minority of the Court considering

]]>The Supreme Court has ruled that the absolute exemption contained in s.32(2) of the Freedom of Information Act 2000 (“FOIA“) continues to apply to information obtained or created by a person conducting an inquiry even after the termination of that inquiry. The decision was not without dissent, however, with the minority of the Court considering that interpretation to amount to a disproportionate interference with the appellant’s Article 10 rights.

Background

Between 2003 and 2005, the Charity Commission conducted three inquiries in relation to the “Mariam Appeal”, an appeal launched by George Galloway MP in 1998 in response to sanctions imposed on Iraq following the first Gulf War. Following two brief reports issued as a result of these inquiries, Dominic Kennedy, a journalist with The Times, made a request to the Charity Commission seeking disclosure of connected documentation under FOIA.

The Charity Commission refused Mr Kennedy’s request, pointing to s.32(2) FOIA, which sets out an absolute exemption for information held by a public authority only by virtue of being contained in any document obtained or created by a person “conducting an inquiry or arbitration, for the purposes of the inquiry or arbitration“. On 20 March 2012, the Court of Appeal, overturning the First-Tier Tribunal, endorsed the Charity Commission’s refusal.

Counsel for Mr Kennedy argued that the s.32(2) exemption applies only until the end of the relevant inquiry. The Supreme Court disagreed, holding that, as a matter of ordinary statutory construction, the absolute exemption under s.32(2) FOIA lasts until the relevant information is destroyed or, if it is not destroyed, when the document becomes a “historical record” for the purposes of the Public Records Act 1958.

The effect of s.32(2) FOIA is not, however, to exclude any duty of disclosure. Rather, according to the majority, this absolute exemption merely means that the relevant documents fall outside the scope of FOIA, and any questions as to their disclosure fall to be addressed “under different and more specific schemes and mechanisms“. In this case, in Lord Mance’s opinion, the statutory duties set out in the Charities Act 1993 and the general common law duties of public authorities gave the Charity Commission the power to disclose information to the public concerning inquiries it has conducted. FOIA in no way limits such a power: s.78 provides that “[n]othing in this Act is to be taken to limit the power of a public authority to disclose information held by it“.

On this basis, Mr Kennedy, who had only ever pursued his claim for disclosure by reference to FOIA, could also have requested the material at common law and then sought judicial review of any refusal by the Charity Commission to provide it. In the circumstances, any such decision would be subject to a very high standard of review: according to Lord Mance, “the proper functioning and regulation of charities is a matter of great public importance and legitimate interest” and the Charity Commission should therefore accede to requests for disclosure such as Mr Kennedy’s “except so far as the public interest in disclosure is demonstrably outweighed by any countervailing arguments that may be advanced“. Lord Toulson reached a similar conclusion on the basis that “[t]he considerations which underlie the open justice principle in relation to judicial proceedings apply also to those charged by Parliament with responsibility for conducting quasi-judicial hearings“.

Article 10 of the European Convention on Human Rights

Mr Kennedy also argued that the s.32(2) exemption was incompatible with his rights under Article 10 of the European Convention on Human Rights (the “ECHR“). The majority held that, even if Article 10 were applicable, there would be no reason to regard FOIA in isolation as the only “route by which the United Kingdom has chosen to give effect to any rights to receive information which Mr Kennedy may have“. On the contrary, the Charities Act 1993 and the common law should be considered and, in the circumstances, put Mr Kennedy in no less favourable a position than if Article 10 were engaged.

Having discussed the conflicting jurisprudence of the European Court of Human Rights (the “ECtHR“), the Court rejected Mr Kennedy’s submission, based on recent ECtHR decisions such as Österreichische Vereinigung zur Erhaltung, Stärkung und Schaffung, that Article 10 should be regarded as conferring “a positive right to receive information from public authorities and […] a correlative obligation on public authorities to impart information“, the majority holding that Article 10 imposes no such free-standing duty of disclosure on public authorities. The recent developments in ECtHR case law were insufficient to justify a departure from the well-established interpretation of that article.

Lord Wilson and Lord Carnwath, in minority judgments, disagreed, considering that Article 10 did provide Mr Kennedy with a free-standing right to receive the requested information and that the absolute exemption in s.32(2) FOIA violated this right. As a result, s.32(2) FOIA should be “read down” under s.3 of the Human Rights Act 1998 so as to imply an exemption which expires at the end of the relevant inquiry, which would be compatible with Mr Kennedy’s Article 10 rights. According to Lord Carnwath, this approach would preserve FOIA as the mechanism for obtaining information from public authorities, which would be in many respects more convenient than the judicial review procedure envisaged by the majority.

Comment

Two main points of interest arise from the Supreme Court’s decision. First, the majority gave a clear indication that it does not (yet) regard the recent developments in Strasbourg jurisprudence on Article 10 ECHR as sufficient to establish a free-standing duty of disclosure for public authorities where no such duty exists in domestic law. Second, the Court’s reading of s.32(2) FOIA implies that even if Article 10 were to confer a right to receive information from public authorities, it would not be sufficient for an applicant to claim that an exemption set out in FOIA violates this right – in each case, the statutory and common law regime for disclosure outside FOIA should also be taken into account in assessing compliance with Article 10 ECHR.

]]>A right royal mess: Court of Appeal quashes FOIA veto for first timehttps://www.hlregulation.com/2014/03/13/a-right-royal-mess-court-of-appeal-quashes-foia-veto-for-first-time/
Thu, 13 Mar 2014 11:27:21 +0000http://www.hlregulation.com/?p=6031In a judgment handed down yesterday, the Court of Appeal has – for the first time – quashed a decision of the Attorney General (“AG“) to veto an Upper Tribunal (“UT“) order that documents be disclosed under the Freedom of Information Act 2000 (“FOIA“). The case relates to a number of letters written by Prince

]]>In a judgment handed down yesterday, the Court of Appeal has – for the first time – quashed a decision of the Attorney General (“AG“) to veto an Upper Tribunal (“UT“) order that documents be disclosed under the Freedom of Information Act 2000 (“FOIA“).

The case relates to a number of letters written by Prince Charles to various Government departments between 2004 and 2005. An application for disclosure by a Guardian journalist, Rob Evans, under FOIA and the Environmental Information Regulations 2004 (the “EIRs“) was initially rejected by the departments in question, and that decision was upheld on appeal by the Information Commissioner. However, the UT overturned the Information Commissioner’s ruling in a judgment dated 18 September 2012, described by the Master of the Rolls as “a most impressive piece of work“, which ordered disclosure of “advocacy correspondence” (that is, “correspondence in which the Prince of Wales advocated certain causes which were of particular interest to him“). On 16 October 2012, the AG exercised his power as an “accountable person” under s. 53(2) FOIA to issue a certificate overriding the UT’s decision to order disclosure, on the basis that (as required by that section) he had “reasonable grounds” to consider that the departments concerned had been entitled to refuse disclosure.

Mr Evans sought to quash the AG’s decision by way of judicial review, but the Divisional Court dismissed his application on 9 July 2013 (that decision was discussed in our previous blog on this case). On appeal, in the current case – R (Evans) v HM Attorney General [2014] EWCA Civ 254 – the Court of Appeal overturned the decision of the Divisional Court.

The correct approach to section 53(2) FOIA

Lord Dyson, the Master of the Rolls, concluded that it was not reasonable for the AG to issue a s. 53(2) certificate simply because he disagreed with the decision of the UT (which was an independent court that had examined the question in “meticulous detail“): “[s]omething more [was] required“, such as a material change of circumstances or that the UT decision was “demonstrably flawed in fact or law“. Lord Dyson also noted that, were s. 53(2) to have the effect that followed from the Divisional Court’s reasoning (ie that the “accountable person” be required only to show that his reasons for disagreeing with the tribunal were, of themselves, sensible and rational), it would be:

a remarkable provision, not only because of its constitutional significance…but also because it [would] seriously undermine the efficacy of the rights of appeal [under FOIA].

As for the reasonableness of the AG’s substantive grounds for issuing the certificate (ie that the public interest was best served by withholding the information from disclosure), the Court repeated that it was insufficient for the AG simply to disagree with the UT’s assessment of the public interest, and his grounds had therefore not been “reasonable”.

Compatibility with EU law

Article 6(2) of the Environmental Information Directive (the “Directive“) requires member states, in respect of environmental information, to provide access to a court (or other body established by law) that can review acts and omissions of a public authority that has refused to disclose information. That court must be able to make final decisions that are to be binding on the public authority. The Divisional Court had held that those requirements were met by the existence of the right to seek judicial review of the decision to issue a certificate under s. 53(2). Conversely, counsel for Mr Evans argued that, in order to be compatible with the rights conferred by EU law (including under article 47 of the EU Charter of Fundamental Rights (the “Charter“)), s. 53(2) should be read so as to preclude the exercise of the veto power where a tribunal has ruled that environmental information must be disclosed.

The Court of Appeal preferred the approach of counsel for Mr Evans for three reasons:

Judicial review would be concerned with the reasonableness of the decision of the “accountable person”, rather than whether the public authority had acted in accordance with FOIA or the EIRs.

The veto of a court or tribunal decision by executive action was incompatible with the requirements under the Directive that that court or tribunal decision be “final” and “binding”. It was no answer that the executive veto could be subject to judicial review, an application for which could, among other things, simply fall at the procedural hurdle.

The Court noted that a party whose rights were violated had the right to an effective remedy under article 47 of the Charter. By virtue of article 52, the scope of that right corresponds with the rights enshrined in article 6 of the European Convention on Human Rights. Referring to the jurisprudence of the European Court of Human Rights, the Court of Appeal concluded that the principles of legal certainty and equality of arms were not met in this case; that position was not remedied by the availability of judicial review.

For these reasons, the Court held that, in so far as environmental information was concerned, the AG’s certificate was incompatible with EU law and should be quashed. Further, the Court went on to quash the certificate in its entirety (ie also in relation to non-environmental information), since the AG had, in the Court’s view, failed properly to consider whether the public interest test would require disclosure of that non-environmental information even if (contrary to the AG’s preference) the environmental information was to be disclosed.

Comment

In an era of ever-increasing scrutiny of Government – including by the Court – yesterday’s Court of Appeal decision is likely to reverberate through the corridors of Whitehall. That said, there may be some consolation for the AG, as permission has been granted to appeal to the Supreme Court. Given the constitutional significance of the questions involved, it would be surprising if that appeal were not pursued.